Linker Information
General Information of This Linker
| Linker ID |
LIN0ZTLCQ
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| Linker Name |
Bis-sulfone-(PEG24)-Glu-Val-Cit-PAB
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| Antibody-Linker Relation |
Cleavable
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| Structure |
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Each Antibody-drug Conjugate Related to This Linker
Full Information of The Activity Data of The ADC(s) Related to This Linker
NN3201 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible subjects (≥18 years, ECOG 0-1) must have advanced c-Kit+ tumors (GIST, SCLC, ACC, uveal melanoma, NET ChRCC/ccRCC) refractory to standard therapies, including imatinib for GIST. Required washout periods: 21 days (chemotherapy), 14 days (targeted therapy), 28 days (immunotherapy). Exclusions include active brain metastases, uncontrolled infections, significant cardiovascular disease, recent major surgery, COVID-19 infection, or pregnancy. Adequate organ function and contraception (120 days post-treatment) are mandatory.
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| Related Clinical Trial | |||||
| NCT Number | NCT06805825 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Dose Escalation and Expansion Study of the C-Kit Specific Antibody-Drug Conjugate NN3201 in Subjects with Advanced And/or Metastatic Solid Tumors Known to Express C-Kit
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| Primary Endpoint |
The study evaluates safety by assessing dose-limiting toxicities (DLTs) within 3 weeks post-treatment, defined as clinically relevant AEs per NCI CTCAE v5.0 that are attributed to NN3201. Adverse event incidence (severity, seriousness, and drug relationship) is monitored over 1 year.
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| Other Endpoint |
The trial determines optimal doses for expansion cohorts (within 1 year) by analyzing anti-tumor efficacy and acceptable safety profiles. Pharmacokinetic (PK) analysis measures NN3201 serum concentration over 3 years, while RECIST 1.1 assesses anti-tumor activity. Promising doses may advance to future studies based on sustained efficacy and safety (3-year timeframe).
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References